PROCLEIX^® ULTRIO^® Assay

Overview

Combining 3 tests in a single tube, the ULTRIO Assay is a qualitative in-vitro nucleic acid amplification test for the detection of HIV-1 RNA, HCV RNA, and HBV DNA in plasma and serum specimens from human donors. Because ULTRIO tests for 3 markers simultaneously, it represents a powerful and efficient solution for your blood screening needs.

 

 

Benefits

Reduced risk of transfusion transmitted infections

In the world of blood screening, confidence in results is of critical importance. While ELISA blood screening technology relies on the detection of serological markers, these markers may not appear in blood until up to 3 months after an infection, leaving a “window period” in which a risk of transfusion-transmitted infection is increased. The PROCLEIX ULTRIO Assay reduces this window period by detecting the presence of the viral RNA or DNA directly. Scientific models estimate that NAT significantly reduces the infectious window period in both individual and mini-pool donation testing formats.

Figure 1: Scientific models estimate that NAT reduces the infectious window period by 35-91% for HIV-1, HCV, and HBV with individual donation testing (IDT), and by 17 to 87% with mini-pool (pools of 16) nucleic acid testing.^1,2

 

Optimal nucleic acid testing flexibility and efficiency

Achieve maximum flexibility with the ability to run ULTRIO on either the semi-automated PROCLEIX^® System, ideal for low- to medium-volume laboratories, or the fully automated Procleix TIGRIS^® NAT System for mid- to high-volume laboratories. PROCLEIX ULTRIO allows laboratories to:

• Gain workflow efficiencies when running Procleix assays on the PROCLEIX TIGRIS System for full automation of NAT
• Perform multiplex screening and discriminatory NAT on the same PROCLEIX platform
• Screen whole blood, organ and tissue, or plasma all in same assay; intended usage also includes cadaveric blood samples and source plasma, as well as the ability to run heparinized samples

 

Exceptional assay performance

Developed using probes and primers designed to increase detection of different viral subtypes, the PROCLEIX ULTRIO Assay provides excellent specificity and analytical sensitivity for the combined detection of HIV-1, HCV, and HBV. The PROCLEIX ULTRIO Assay offers:

• Ability to detect HCV genotypes 1-6³
• Redundant detection via primers targeting 2 highly conserved regions of the HIV-1 gene to help prevent HIV-1 mutant break-through transmissions⁴

References

1. Busch, MP, Evolving Approaches to Estimate Risks of Transfusion-Transmitted Viral Infections: Incidence-Window Period Model after Ten Years. Dax EM, Farrugia A, Vyas GN (editors): Advances in Transfusion Safety – Volume IV, Developments in Biologicals (Basel), Basel, Karger, 2007, vol 127, pp 87-112.
2. Kleinman SH, Busch MP, Assessing the impact of HBV NAT on window period reduction and residual risk, J Clin Virol 36 Suppl. 1 (2006) S23-S29.
3. Assal A et al. Comparison of the analytical and operational performance of two viral nucleic acid test blood screening systems: Procleix Tigris and cobas s 201. Transfusion. (2009) 49:289-300
4. Giachetti, C. et al. Highly Sensitive Multiplex Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA. J Clinical Microbiology (2002) 40(7):2408-2419
5. Data from Procleix ULTRIO Assay US Package Insert 501807 Rev A run on the TIGRIS PROCLEIX System
6. Davis C, Heath A, Best S, Hewlett I, Lelie N, Schuurman R and Holmes H. Calibration of HIV-1 working reagents for nucleic acid amplification techniques against 1st international standard for HIV-1 RNA. J Virological Methods 107 (2003) 37-44

 

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